Results of the Phase II QUADRA and Phase III CORAIL clinical trials exploring novel therapies in women with platinum-resistant ovarian cancer were recently presented at the 2018 European Society for Medical Oncology (ESMO) Meeting in Munich, Germany.
"The prognosis for patients with platinum-resistant ovarian cancer is dismal, and they have limited treatment options. Both these trials explored novel therapies in this disease setting," explained Angeles Alvarez Secord, MD, Duke Ob/Gyn gynecologic oncologist and co-author for the QUADRA trial.
The CORAIL multicenter randomized clinical trial compared lurbinectedin versus commonly used standard of care drugs (liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer patients. Dr. Stephanie Gaillard, the study’s first author, oversaw the trial when she was an Assistant Professor in Medical Oncology at the Duke Cancer Institute and presented the findings at ESMO. Duke University is the lead site listed in the study. Recruitment ended on October 14, 2016 at 442 patients. Seven patients from Duke Cancer Institute were included in the trial. Unfortunately, the trial did not meet its primary endpoint and the efficacy results (PFS, ORR, OS) were no different across arms.
"While it is unlikely the company will go for registration, it is clear that the drug has some anti-tumor activity. We will see what the future holds for development,” said Dr. Secord.
The QUADRA phase II multicenter open-label single arm trial evaluated niraparib, a PARP inhibitor, in patients with relapsed ovarian cancer. This study included 463 patients, many with platinum refractory or resistant disease treated with multiple lines of chemotherapy. Over 30 patients from the Duke Cancer Institute were enrolled. The findings revealed an impressive response rate of 31% in women with tumors harboring BRCA mutations treated with 4th line or later therapy. Niraparib demonstrated a high response rate in women with platinum-sensitive disease (39%), as well as those with platinum-resistant (33%), and platinum-refractory (19%) disease. An estimated 43% of patients who responded to therapy maintained their response at 24 months.
"These are very exciting findings. The patients included in this study have heavily pretreated disease. The typical response to chemotherapy beyond 4th line is less than 10%. A BIG thank you to our research team for all their hard work and to our patients who participate on these important studies. Clinical trials hold the key to curing cancer and enhancing survival for our patients."
Dr. Gaillard is currently at Johns Hopkins University, but also holds an adjunct position at Duke Cancer Institute. Drs. Secord and Gaillard continue to focus on treating patients with gynecologic malignancies and conducting translational research. Currently they are exploring immunotherapies and collaborating in ovarian and endometrial clinical trials.